MAUDE Adverse Event Report: CAREFUSION, INC PLEURX VALVE KIT; APPARATUS, SUCTION, PATIENT CARE

Model Number	50-7270
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) initial and final emdr submission.Device problem code: a0504, patient problem code: f26.No photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Should you experience any problems with our product, examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
Event or Problem Description
It was reported by the customer that "call transferred from product complaints and agent remained on the call.Surgeon requesting troubleshooting assistance with the pleurx device for on of her patients.She states the patient is 90 years old and has a malignant pleural effusion.She had the pleurx device for one month and the device started leaking.She placed a purse string suture and changed the frequency of the draining procedures, and the leaking did improve but states now the device is clogged.States the patient does not have any signs of infection around the catheter site".Verbatim: rcc received a complaint via email.Call transferred from product complaints and agent remained on the call.Surgeon requesting troubleshooting assistance with the pleurx device for on of her patients.She states the patient is 90 years old and has a malignant pleural effusion.She had the pleurx device for one month and the device started leaking.She placed a purse string suture and changed the frequency of the draining procedures and the leaking did improve but states now the device is clogged.States the patient does not have any signs of infection around the catheter site.Explained if fluid is loculated away from the catheter, then changing positions may push the fluid toward the catheter.If the fluid goes away suddenly or if the amount of drainage gradually declines, it is possible that the catheter or drainage line may be clogged.Squeeze the catheter and the drainage line gently.If drainage does not begin, follow the instructions for changing to another bottle.If the drainage does not start when you use a second bottle, we recommend contacting the doctor.Also, recommended checking the valve to see if the valve is damaged.We do offer an emergency valve replacement kit (ref 50-7270).

• Brand Name: PLEURX VALVE KIT
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 17277510
• Report Number: 1625685-2023-00068
• Device Sequence Number: 14322795
• Product Code: DWM
• UDI-Device Identifier: 10885403420528
• UDI-Public: (01)10885403420528
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 50-7270
• Device Catalogue Number: 50-7270
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female